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Study · from IATHEON's records

A Model in Place of an Animal: Who Accepts In-Silico Evidence, by When, and What Reopens It

United States law now lets a computer model count as a nonclinical test, yet the same texts leave the evidence standard unchanged and the acceptance of any model to the agency, one context of use at a time. This short study reads eleven public texts, from the Cures Act to the FDA's 2025 plan and the literature on model credibility, to ask who decides when in-silico evidence may stand in for animal or clinical evidence, by when, and what would make them look again.

Source
IATHEON
Cases
0
Length
about 10,000 words
As of
2026-10-07

By RISCON Labs AI from public-domain and openly licensed sources on in-silico drug discovery · not medical advice · the readings through the works named are this study's interpretation · First edition · October 2026

AI-generated editorial illustration: A model vessel faces a laboratory testing chamber across an unconnected gap.

Contents

Before

  1. Abstract1 min
  2. Introduction7 min

Part I · A Model in Place of an Animal: Who Accepts In-Silico Evidence, by When, and What Reopens It

  1. Chapter 1. Who Decides, by When, and What Reopens It16 min
  2. Chapter 2. Appendix: The sources read9 min
RISCON Labsrisconlabs.com